Adolescent Idiopathic Scoliosis
Conditions
Keywords
AIS
Brief summary
The purpose of this study is to gain initial experience and information for proper planning and conduct of a confirmatory study (a multi-centre single-blind comprehensive cohort study of bracing).
Detailed description
The study has been completed.
Interventions
DEVICEBrace
Wearing a Thoraco-Lumbo-Sacral-Orthosis (TLSO) for a minimum of 20 hours per day
Sponsors
Scoliosis Research Society
The University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
10 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Diagnosis of AIS 2. Age ≥10 years 3. Risser sign 0-2 4. Cobb's angle 20 deg to \<25 deg with documented deterioration of at least 5 deg within the past 4 months (with a maximum of 10 days deviation), or 25 deg to \<30 deg
Exclusion criteria
1. History of treatment of AIS 2. \>= 1 year postmenarchal (for girls only) 3. Physical or mental disability to adhere to bracing 4. Diagnosis of musculoskeletal or development illness that might be responsible for the spinal curvature 5. Structural thoracic scoliosis with apex above T7 (Note these patients are not suitable for under-arm brace) 6. Difficulty to read, understand, and complete the study questionnaires 7. Any criteria, which, in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to >= 6 degree curve progression from baseline, Time to curve exceeding 45 degree, Time to surgery recommended/undertaken. | Baseline and every four months |
Secondary
| Measure | Time frame |
|---|---|
| SRS-22 questionnaire, C-STAI questionnaire, C-BDI-II. | Baseline and every four months |
Countries
China
Outcome results
None listed